Overview

Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer

Status:
Terminated

Trial end date:
2013-05-01

Target enrollment:
0

Participant gender:
All

Summary

The study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or compare individual regimen but rather it will test the approach of customization concept as a whole. The results of this pilot study will help in designing more definitive trials in our patient population.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Guard Health Affairs

Treatments:

Cisplatin
Docetaxel
Gemcitabine

Criteria

Inclusion Criteria:

1. Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV

2. Having adequate tissue sample to perform the markers testing

3. Age ≥ 18 years

4. No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are
acceptable)

5. No other concurrent cancer treatment

6. Performance status of 0- 2 per ECOG scale (Appendix II)

7. Adequate laboratory values as follows as follows:

Absolute neutrophil count ≥ 1500/mm3 Platelet count ≥100, 000/ mm3 Total bilirubin ≤
1.25X institutional upper normal level AST and ALT ≤ 3 X institutional upper normal
level Serum creatinine ≤ 1.5 X institutional upper normal level

8. Presence of measurable disease

Exclusion Criteria:

1. Prior systemic treatment for lung cancer

2. History of hypersensitivity to drugs used

3. Diagnosis of other malignancy in the last 5 years excluding curatively treated
non-melanoma skin cancer and in-situ cervical cancer

4. Medical illness that puts the patient at significant risk per investigator's
discretion

5. Uncontrolled CNS disease. Patients with CNS metastatic disease treated with
radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after
the treatment initiation without increase dose of steroids

6. Positive pregnancy test or refusal to use contraception during treatment. (Gynecology
consultant for contraception)